This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

A.P. Pharma Provides Regulatory Update On APF530 NDA

A.P. Pharma, Inc. (OTCQB: APPA), a specialty pharmaceutical company, today provided an update on its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Company management and consultants met with the U.S. Food and Drug Administration (FDA) on March 31, 2011 to discuss certain aspects of the Complete Response Letter issued by the FDA for the APF530 New Drug Application (NDA). This meeting followed an earlier meeting held with the FDA in February 2011 to discuss clinical and clinical pharmacology issues raised in the Complete Response Letter.

“A.P. Pharma has had two productive meetings with the FDA, which have helped clarify the work needed to resubmit the APF530 NDA,” said John Whelan, A.P. Pharma’s president and chief executive officer. “Based on our discussions with the FDA and our assessment of the work remaining, we expect to resubmit the APF530 NDA during the first half of 2012.”

At the March meeting, the Company presented information concerning the product dosing system for APF530 and the characterization and manufacture of APF530. The primary topics discussed with the FDA are described below:

  • The Company proposed replacing its former, two-syringe dosing system with a new, single-syringe system it has developed over the past year. The Company believes that the new system offers significant safety and convenience advantages over the old system. The FDA acknowledged that the single-syringe design would be an improvement, suggested certain labeling enhancements, and requested additional, non-clinical, human factors studies be conducted prior to resubmission.
  • The FDA agreed to the Company’s plan to switch to terminal sterilization of the filled product syringes.
  • The Company presented additional characterization data, analytical data and revised specifications for APF530 and its constituent materials. Previously, the FDA suggested a bioavailability study would be necessary to compare materials manufactured at two separate manufacturing sites. Based on the discussions with the FDA, the Company does not see a need for a bioavailability study at this time.
  • The FDA clarified which assays will be required for controlling the manufacture and quality of APF530. The Company plans to make and analyze additional lots of APF530 prior to resubmission.
  • Based on the February meeting with the FDA, the Company plans to conduct a clinical study that will serve as both a thorough QT study and a metabolism study. The FDA agreed that these studies could be combined into a single study conducted in healthy volunteers.
  • Also at the February meeting, the FDA indicated that the revised presentation format for the pivotal Phase 3 clinical data was acceptable for resubmission and did not request any additional efficacy studies.

The Company is currently targeting resubmission of the APF530 NDA for the first half of 2012. The FDA’s review will likely take a minimum of six months. The Company has not yet received written minutes for the March meeting from the FDA, and the FDA will make its final decision once it reviews the full APF530 NDA resubmission.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 17,826.30 -279.47 -1.54%
S&P 500 2,081.18 -23.81 -1.13%
NASDAQ 4,931.8150 -75.9760 -1.52%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs